[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595170":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":16,"studyPopulation":17,"armGroups":18,"interventions":23,"overallOfficials":29,"centralContacts":37,"locations":43,"responsibleParty":121,"collaborators":11,"id":123,"slug":11,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":11,"eligibilityCriteria":127,"healthyVolunteers":124,"sex":128,"minAge":11,"maxAge":11,"enrollmentInfo":129,"targetDuration":132,"studyType":133,"phases":11,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":73,"whyStopped":11,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Nanjing IASO Biotechnology Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"To evaluate the safety profile of Equecabtagene Autoleucel Injection in treated patients.",null,"Up to 15 years from enrollment",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":14,"timePerspective":15,"maskingInfo":11},"COHORT","PROSPECTIVE","The main follow-up period for pre-marketing clinical studies related to Equecabtagene Autoleucel Injection is 2 years. The \"Technical Guidelines for Long-term Follow-up Clinical Studies of Gene Therapy Products (Trial)\" issued by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) recommends a follow-up period of not less than 15 years for gene therapy products with genomic integration activity.\n\nIn order to observe the long-term safety and efficacy of Equecabtagene Autoleucel Injection, as well as the persistence of CAR-T cells in vivo, and to identify whether there are differences in safety among populations with different indications, this study will conduct long-term follow-up in patients treated with Equecabtagene Autoleucel Injection, thereby identifying long-term risks and helping to evaluate the product's benefit-risk profile.","All patients who have received Equecabtagene Autoleucel Injection treatment. Patients who participated in pre-marketing clinical studies or post-marketing real-world studies with this product can only be enrolled after completing or prematurely withdrawing from their original studies.",[19],{"label":20,"type":11,"description":11,"interventionNames":21},"All patients received Equecabtagene Autoleucel Injection",[22],"Other: No Intervention (subjects were previously treated with Equecabtagene Autoleucel Injection) )",[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"OTHER","No Intervention (subjects were previously treated with Equecabtagene Autoleucel Injection) )","This study is observational study and all participants will be obsreved with no intervention.",[20],[30,34],{"name":31,"affiliation":32,"role":33},"Jian Li, PhD","Peking Union Medical College Hospital","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Juan Du, PhD","RenJi Hospital",[38],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Wen Ye","CONTACT","+86 025-58287610","wen.ye@iasobio.com",[44,61,71,85,95,108],{"facility":45,"status":46,"city":47,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Peking University First Hospital","NOT_YET_RECRUITING","Beijing","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57],{"name":58,"role":40,"phone":59,"phoneExt":11,"email":60},"Yujun Dong","+86 18210264969","dongy@hsc.pku.edu.cn",{"facility":62,"status":46,"city":47,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"People's Hospital of Peking Universit",{"type":51,"coordinates":64},[53,54],{"lat":54,"lon":53},[67],{"name":68,"role":40,"phone":69,"phoneExt":11,"email":70},"Jin Lu","+86 13311491805","jin1lu@sina.com",{"facility":72,"status":73,"city":74,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences","RECRUITING","Tianjin",{"type":51,"coordinates":76},[77,78],117.17667,39.14222,{"lat":78,"lon":77},[81],{"name":82,"role":40,"phone":83,"phoneExt":11,"email":84},"Dehui Zou","+86 13602100955","zoudehui@ihcams.ac.cn",{"facility":86,"status":73,"city":74,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"Tianjin Medical University General Hospital",{"type":51,"coordinates":88},[77,78],{"lat":78,"lon":77},[91],{"name":92,"role":40,"phone":93,"phoneExt":11,"email":94},"Rong Fu","+86 13920350233","furong8369@tmu.edu.cn",{"facility":96,"status":46,"city":97,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan",{"type":51,"coordinates":99},[100,101],114.26667,30.58333,{"lat":101,"lon":100},[104],{"name":105,"role":40,"phone":106,"phoneExt":11,"email":107},"Chunrui Li","+86 13647233185","cunrui5650@126.com",{"facility":109,"status":46,"city":110,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University","Zhengzhou",{"type":51,"coordinates":112},[113,114],113.64861,34.75778,{"lat":114,"lon":113},[117],{"name":118,"role":40,"phone":119,"phoneExt":11,"email":120},"Baijun Fang","+86 13526607830","fdation@126.com",{"type":122,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100595170",false,"NCT07028970","Long-term Follow-up Registry Study of Equecabtagene Autoleucel Injection","Inclusion Criteria:\n\n\\- 1.Received Equecabtagene Autoleucel Injection treatment; 2.For those who participated in pre-marketing clinical studies or post-marketing real-world studies, must have completed or withdrawn from the original study; 3.Voluntary signing of an informed consent form approved by the ethics committee.\n\nExclusion Criteria:\n\n* 1\\. Receipt of another lentiviral vector-based cell or gene therapy (either commercialized product or investigational product in a clinical tiral) between the infution of Equecabtagene Autoleucel Injection and the signing informed consent.","ALL",{"count":130,"type":131},1500,"ESTIMATED","15 Years","OBSERVATIONAL","This is a multicenter, open-label, single-arm, long-term follow-up clinical study. All patients who have received Equecabtagene Autoleucel Injection treatment will be enrolled.",[136],"Multiple Myeloma",[138,139],"Long term follow up;","Eque-cel","2025-06-11",{"date":142,"type":143},"2025-06-19","ACTUAL",{"date":145,"type":143},"2024-12-15",{"date":147,"type":131},"2043-12",{"name":5,"class":6},6]